Why it was recalled
Failed Content Uniformity Specifications
Product description
TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512.
Lot numbers, UPCs & expiration codes
a) Lot# 82579; Exp. 10/16 b) Lot:# 85088 Exp. 05/17
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0099-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 30, 2016
- FDA report date
- Oct 19, 2016
- Quantity
- 25,247 tubes (19,499 30 gram/ 5,748 100 gram)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Allergan Sales, LLC
Original FDA data
Every field from FDA enforcement report D-0099-2017, exactly as published.
Show all FDA fields
- City
- Waco
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 74623
- Address
- 8301 Mars Dr
- Code information
- a) Lot# 82579; Exp. 10/16 b) Lot:# 85088 Exp. 05/17
- Postal code
- 76712-6578
- Report date
- Oct 19, 2016
- Product type
- Drugs
- Recall number
- D-0099-2017
- Classification
- Class II
- Recalling firm
- Allergan Sales, LLC
- Product quantity
- 25,247 tubes (19,499 30 gram/ 5,748 100 gram)
- Termination date
- Dec 6, 2017
- Reason for recall
- Failed Content Uniformity Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 30, 2016
- Initial firm notification
- Letter
- Center classification date
- Oct 13, 2016